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Valbenazine

Alternative Names: valbenazine, nbi-98854, ingrezza, mt-5199, mt5199, mt 5199, nbi98854
Latest Update: 2024-12-19
Latest Update Note: Clinical Trial Update

Product Description

Valbenazine is a modified metabolite of the vesicular monoamine transporter 2 (VMAT-2) inhibitor tetrabenazine, which is approved for the treatment of the hyperkinetic movement disorder, Huntington's disease. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/28742396/)

Mechanisms of Action: VMAT2 Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Orphan Drug - Chorea|Huntington Disease *

Approval Status: Approved

Approved Countries: Indonesia | Japan | Malaysia | Singapore | United States

Approved Indications: None

Known Adverse Events: None

Company: Neurocrine
Company Location: SAN DIEGO CA 92130
Company CEO: Kevin C. Gorman
Additonal Commercial Interests: Mitsubishi Tanabe

Clinical Description

Map of Global Clinical Trials for Valbenazine

Countries in Clinic: Argentina, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Italy, Poland, Portugal, Romania, Serbia, Slovakia, Spain, United States

Active Clinical Trial Count: 9

Highest Development Phases

Phase 3: Cerebral Palsy|Chorea|Dyskinesias|Huntington Disease|Paralysis|Schizophrenia

Phase 2: Trichotillomania

Phase 1: Tardive Dyskinesia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
NBI-98854-HD3022

P3

Enrolling by invitation

Huntington Disease|Chorea

2026-04-01

95%
NBI-98854-HD3006

P3

Active, not recruiting

Huntington Disease|Chorea

2026-03-01

95%
NBI-98854-DCP3018

P3

Unknown Status

Cerebral Palsy

2026-01-16

No NIH funding

P1

Recruiting

Dyskinesias|Tardive Dyskinesia

2025-10-18

Recent News Events

Date

Type

Title

11/07/2024

News Article

 Neurocrine Biosciences Presents New KINECT®-HD Data Showing Consistent Efficacy Across 19 Subgroups and Improvements in Aspects of Emotional Health With INGREZZA® (valbenazine) Capsules

11/01/2024

News Article

 Teva Presents New Tardive Dyskinesia Data at Psych Congress 2024 from the IMPACT-TD Registry, Revealing Differences in Patient Experience Based on Underlying Psychiatric Condition

09/30/2024

News Article

 Neurocrine Biosciences Presents Interim Data Demonstrating Robust and Sustained Improvements in Chorea Associated With Huntington's Disease Through Week 104 Irrespective of Antipsychotic Use

07/18/2024

News Article

 Neurocrine Biosciences Launches INGREZZA® SPRINKLE (valbenazine) Capsules to Ease Administration for Patients Experiencing Dysphagia or Difficulty Swallowing

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